Important Regulatory Note:
Methylene Blue is a synthetic compound with a long history of medical use. While it is FDA-approved for specific indications (e.g., treatment of methemoglobinemia), it is often used off-label and in compounded form for wellness purposes including cognitive enhancement, mitochondrial support, and neuroprotection. These off-label uses have not been reviewed or approved by the FDA, and compounded versions are not FDA-evaluated.

Intended Use (Off-Label):
In wellness and anti-aging protocols, methylene blue may be prescribed at low doses to:

• Support mitochondrial function
• Enhance cellular energy production (ATP synthesis)
• Promote cognitive clarity and memory
• Act as a neuroprotective antioxidant

Contraindications:
Do not use if you:

• Are allergic to methylene blue or thiazine dyes
• Are currently taking SSRIs, SNRIs, MAOIs, or serotonergic medications
• Have G6PD deficiency (risk of hemolysis)
• Are pregnant or breastfeeding
• Have severe renal or hepatic impairment without medical clearance
  
  

Warnings & Serious Risks:

• Serotonin syndrome: Methylene blue has MAOI activity and can cause serotonin syndrome if combined with serotonergic drugs
• Hemolytic anemia: Risk is increased in patients with G6PD deficiency
• Confusion, agitation, or mood changes: May occur with high doses or drug interactions
• Discoloration: May temporarily turn urine blue or green, and stain skin or mucous membranes
• Overdose risk: High doses may cause respiratory distress, confusion, or methemoglobinemia
  
  

Common Side Effects:

• Blue or green urine
• Gastrointestinal upset (nausea, abdominal pain)
• Headache
• Dizziness or lightheadedness
• Skin or tongue discoloration
• Mild restlessness or insomnia

Most effects are dose-dependent and reversible.

Drug Interactions:
Do not combine with:

• SSRIs (e.g., sertraline, fluoxetine)
• SNRIs (e.g., venlafaxine)
• MAOIs or other antidepressants
• 5-HTP, St. John’s Wort, or other serotonergic supplements
• Anti-anxiety, antipsychotic, or stimulant medications
  Always consult your provider about medication interactions prior to starting.
  
  

Pregnancy & Breastfeeding:
Methylene blue is not recommended for use during pregnancy due to fetal risk and should be avoided while breastfeeding unless otherwise approved by a specialist.

Administration:
Take orally as prescribed, typically in microdoses. Do not exceed the recommended dose. Capsules may be compounded in low-dose formulations (e.g., <1mg/kg/day). Wash hands after handling.

Storage:
Store in a cool, dry place, away from light. Methylene blue can stain surfaces — keep containers sealed and out of reach of children.

Emergency Situations:
Seek immediate medical attention if you experience confusion, agitation, chest pain, severe headache, trouble breathing, or signs of serotonin syndrome (e.g., high fever, muscle rigidity, rapid heart rate).

Disclaimer:
Methylene blue for cognitive or mitochondrial support is an off-label, compounded use and not FDA-reviewed for this indication. Use only under the guidance of a licensed healthcare provider. This information is for educational purposes and does not substitute for medical advice. Report serious adverse effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.